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Disposable, transnasal versus conventional upper gastrointestinal endoscopy: a diagnostic accuracy study in patients referred for diagnostic evaluation of the esophagus

Withdrawn
Conditions
esophageal lesions
10017943
Registration Number
NL-OMON40705
Lead Sponsor
niversitair Medisch Centrum Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Withdrawn
Sex
Not specified
Target Recruitment
147
Inclusion Criteria

- Indication for diagnostic upper endoscopy to evaluate esophageal disorders
- Age older than 18 years
- Written informed consent

Exclusion Criteria

- Therapeutic endoscopic intervention
- Known bleeding diathesis
- Concurrent anticoagluation therapy
- History of trauma/surgery of nose or nasal cavity
- Recurrent epistaxis ( > 1 episode / 3 months)
- Altered anatomy of the upper gastroesophageal tract due to suergy of the esophagus
- Implantable pacing device

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Diagnostic accuracy of the E.G.Scan 2.0 * compared to conventional upper<br /><br>endoscopy in patients referred for diagnostic upper endoscopy as determined by<br /><br>sensitivity and specificity for upper GI lesions</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- technical success<br /><br>- safety<br /><br>- quality of procedure (evaluated by the endoscopist)<br /><br><br /><br>of the E.G.Scan 2.0 * compared to conventional upper endoscopy in patients<br /><br>referred for diagnostic upper endoscopy evaluate esophageal disorders</p><br>
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